The association between immunosuppressants use and COVID-19 adverse outcomes: national COVID-19 cohort in South Korea.

BACKGROUND: There is uncertainty of the effect of immunosuppression, including corticosteroids, before COVID-19 infection on COVID-19 outcomes. The aim of this study was to investigate the relationship between prehospitalization immunosuppressants use (exposure) and COVID-19 patient outcomes. METHODS: We conducted a population-based retrospective cohort study using a nationwide healthcare claims database of South Korea as of May 15, 2020. Confirmed COVID-19 infection in hospitalized individuals aged 40 years or older were included for analysis. We defined exposure variable by using inpatient and outpatient prescription records of immunosuppressants from the database. Our primary endpoint was a composite endpoint of all-cause death, intensive care unit (ICU) admission, and mechanical ventilation use. Inverse probability of treatment weighting (IPTW)-adjusted logistic regression analyses were used, to estimate odds ratio (OR) and 95% confidence intervals (CI), comparing immunosuppressants users and non-users. RESULTS: We identified 4,349 patients, for which 1,356 were immunosuppressants users and 2,993 were non-users. Patients who used immunosuppressants were at increased odds of the primary endpoint of all-cause death, ICU admission and mechanical ventilation use (IPTW OR =1.32; 95% CI: 1.06-1.63), driven by higher odds of all-cause mortality (IPTW OR =1.63; 95% CI: 1.21-2.26). Patients who used corticosteroids (n=1,340) were at increased odds of the primary endpoint (IPTW OR =1.33; 95% CI: 1.07-1.64). CONCLUSIONS: Immunosuppressant use was associated with worse outcomes among COVID-19 patients. These findings support the latest guidelines from the CDC that people on immunosuppressants are at high risk of severe COVID-19 and that immunocompromised people may benefit from booster COVID-19 vaccinations.

The prognostic role of anticoagulants in COVID-19 patients: national COVID-19 cohort in South Korea.

BACKGROUND: There currently exists a paucity of data on whether pre-admission anticoagulants use may have benefits among COVID-19 patients by preventing COVID-19 associated thromboembolism. The aim of this study was to assess the association between pre-admission anticoagulants use and COVID-19 adverse outcomes. METHODS: We conducted a population-based cohort studying using the Health Insurance Review and Assessment Service (HIRA) claims data released by the South Korean government. Our study population consisted of South Koreans who were aged 40 years or older and hospitalized with COVID-19 between 1 January 2020 through 15 May 2020. We defined anticoagulants users as individuals with inpatient and outpatient prescription records in 120 days before cohort entry. Our primary endpoint was a composite of all-cause death, intensive care unit (ICU) admission, and mechanical ventilation use. Individual components of the primary endpoint were secondary endpoints. We compared the risk of endpoints between the anticoagulants users and non-users by logistic regression models, with the standardized mortality ratio weighting (SMRW) adjustment. RESULTS: In our cohort of 4,349 patients, for the primary endpoint of mortality, mechanical ventilation and ICU admission, no difference was noted between anticoagulants users and non-users (SMRW OR 1.11, 95% CI: 0.60-2.05). No differences were noted, among individual components. No effect modification was observed by age, sex, history of atrial fibrillation and thromboembolism, and history of cardiovascular disease. When applying the inverse probability of treatment weighting (IPTW) and SMRW with doubly robust methods in sensitivity analysis, anticoagulants use was associated with increased odds of the primary endpoint. CONCLUSIONS: Pre-admission anticoagulants were not determined to have a protective role against severe COVID-19 outcomes.

The association between statin and COVID-19 adverse outcomes: national COVID-19 cohort in South Korea.

BACKGROUND: There currently exist limited and conflicting clinical data on the use of statins in coronavirus disease 2019 (COVID-19) patients. The aim of this paper was to compare hospitalized patients with COVID-19 who did and did not receive statins. METHODS: We performed a population-based retrospective cohort study using South Korea's nationwide healthcare claim database. We identified consecutive patients hospitalized with COVID-19 and aged 40 years or older. Statin users were individuals with inpatient and outpatient prescription records of statins in the 240 days before cohort entry to capture patients who are chronic statin users and, therefore, receive statin prescriptions as infrequently as every 8 months. Our primary endpoint was a composite of all-cause death, intensive care unit (ICU) admission, mechanical ventilation use and cardiovascular outcomes [myocardial infarction (MI), transient cerebral ischemic attacks (TIA) or stroke]. We compared the risk of outcomes between statin users and non-users using logistic regression models after inverse probability of treatment weighting (IPTW) adjustment. RESULTS: Of 234,427 subjects in the database, 4,349 patients were hospitalized with COVID-19 and aged 40+ years. In total, 1,115 patients were statin users (mean age =65.9 years; 60% female), and 3,234 were non-users (mean age =58.3 years; 64% female). Pre-hospitalization statin use was not significantly associated with increased risk of the primary endpoint [IPTW odds ratio (OR) 0.82; 95% confidence interval (CI): 0.60-1.11]. Subgroup analysis showed a protective role of antecedent statin use for individuals with hypertension (IPTW OR 0.40; 95% CI: 0.23-0.69, P for interaction: 0.0087). CONCLUSIONS: Pre-hospitalization statin use is not detrimental and may be beneficial amongst hypertensive COVID-19 patients. Further investigation into statin is needed for more conclusive effects of statins for treatment of COVID-19.

Cost-effectiveness analysis of statins for the treatment of hospitalized COVID-19 patients.

BACKGROUND: A recent systematic review and meta-analysis reporting on thirteen published cohorts investigating 110,078 patients demonstrated that patients who were administered statins after their COVID-19 diagnosis and hospitalization were had a lower risk of mortality. While these findings are encouraging, given competing COVID-19 treatment approaches, it is unclear if statin use should be prioritized and if its use is a cost-effective treatment options for hospitalized COVID-19 patients. In this study, we report on a cost-effectiveness analysis of statin-containing treatment regimens for hospitalized COVID-19 patients. METHODS: A Markov model was used to compare statin use and no statin use among hospitalized COVID-19 patients from a United States healthcare perspective. The cycle length was one week, with a time horizon of 4 weeks. A Monte Carlo microsimulation with 20,000 samples were used. All analyses were conducted using TreeAge Pro Healthcare Version 2021 R1.1. RESULTS: The mean cost for patients receiving statins in addition to usual care was $31,623 (SD $20,331), whereas the mean cost for patients not receiving statins was $33,218 (SD $25,440). The mean effectiveness for the two cohorts were 1.73 (SD 0.96) and 1.71 (SD 1.00), respectively. CONCLUSIONS: This analysis demonstrated that treatment of hospitalized COVID-19 patients with statins was both cheaper and more effective than treatment without statins; statin-containing therapy dominates over non-statin therapy. Statin medications for the treatment of COVID-19 should be further investigated in randomized controlled trials, especially considering its cost-effective nature. Optimistically and pending the results of future randomized trials, statins should be considered for use broadly for the treatment of hospitalized COVID-19 patients.

Longitudinal Quantitative Analysis of Radiation Oncology Staff Illness in a New York City Center during COVID-19: The Impact of New Guidelines on Operations and Employee Health.

PURPOSE: The novel coronavirus (COVID-19) forced radiation oncology clinics to overhaul operational policies, but the effect on employee safety has not, to our knowledge, been reported. The New York Proton Center (NYPC), a large freestanding clinic in New York City, New York, presents a 1-month experience of employee-reported health outcomes after the infiltration of COVID-19 and enforcement of policies designed to mitigate its impact. MATERIALS AND METHODS: In March 2020, new operational policies were implemented, including rigorous and frequent sanitation, visitor and treatment restrictions, distribution of personal protective equipment, work-from-home orders, and isolated nursing and radiation therapy teams. Employees of NYPC were prospectively monitored for exposure and symptoms of COVID-19. Work hours lost because of illness or quarantines were quantified from March 1, 2020, to March 31, 2020. RESULTS: Among 95 total employees, 23 (24%) were quarantined because of symptoms (n = 15; 65%), high-risk exposure (n = 5; 22%), or self-quarantined with personal concern (n = 3; 13%). Of 44 full-time, on-site employees, 39% (n = 17, including 6 therapists and 5 nurses) missed significant work time, including 6 (14%) with confirmed COVID-19. At full capacity, NYPC would have used 7260 work hours during March 2020 from the full-time, on-site staff, which was reduced by 18.8% overall (25.2% of nursing and 13.3% of therapy work hours), all in the latter half of the month. Among the therapist lost work hours, 92% were from 2 of 7 distinct, isolated therapy teams (29%). Without isolation, the exposure was modeled to have been 100%. CONCLUSION: Despite losing significant staff hours in our department because of COVID-19, early and aggressive adoption of current, recommended policy guidelines outlined in this manuscript allowed NYPC to continue patient operations at full capacity.

A National Survey of Radiation Oncology Experiences Completing Tele-Consultations During the Coronavirus Disease (COVID-19) Pandemic.

PURPOSE: The emergence of the coronavirus disease (COVID-19) global pandemic has led to a significant shift in the delivery of health care, including an explosive growth of telemedicine services. This reverberated in the field of radiation oncology, with a recent American Society for Radiation Oncology (ASTRO) nationwide survey reporting 89% of surveyed clinics began to offer telemedicine programs to patients because of the pandemic. However, this survey did not study the perceptions and experiences of those clinicians delivering telemedicine services. METHODS AND MATERIALS: We investigated through a national physician survey the merits and limitations of radiation oncology tele-consultations. An anonymous web-based survey was distributed using SurveyMonkey (www.surveymonkey.com) via email. RESULTS: Seventy six respondents (16.1% overall response rate) completed the survey, with broad representation from both academic and community-based practices. Many respondents agreed that transitioning to tele-consultations was a needed step given the emergence of the pandemic, despite most having never previously offered this service. Despite many radiation oncologists having little prior experience with tele-consultations, a majority were satisfied in being able to explain the details of a medical diagnosis, provide results of imaging and bloodwork, and discuss recommendations around radiation treatments through this format. Nearly half of the respondents agreed that tele-consultations felt impersonal, with the inability to complete physical examinations noted as a contributor to the impersonality. Nevertheless, respondents still agreed that telemedicine will play an important role going forward, and almost 90% agreed that they would offer tele-consultations even after the pandemic has resolved.

Practice Recommendations for Lung Cancer Radiotherapy During the COVID-19 Pandemic: An ESTRO-ASTRO Consensus Statement.

BACKGROUND: The COVID-19 pandemic has caused radiotherapy resource pressures and led to increased risks for lung cancer patients and healthcare staff. An international group of experts in lung cancer radiotherapy established this practice recommendation pertaining to whether and how to adapt radiotherapy for lung cancer in the COVID-19 pandemic. METHODS: For this ESTRO & ASTRO endorsed project, 32 experts in lung cancer radiotherapy contributed to a modified Delphi consensus process. We assessed potential adaptations of radiotherapy in two pandemic scenarios. The first, an early pandemic scenario of risk mitigation, is characterized by an altered risk-benefit ratio of radiotherapy for lung cancer patients due to their increased susceptibility for severe COVID-19 infection, and minimization of patient travelling and exposure of radiotherapy staff. The second, a later pandemic scenario, is characterized by reduced radiotherapy resources requiring patient triage. Six common lung cancer cases were assessed for both scenarios: peripherally located stage I NSCLC, locally advanced NSCLC, postoperative radiotherapy after resection of pN2 NSCLC, thoracic radiotherapy and prophylactic cranial irradiation for limited stage SCLC and palliative thoracic radiotherapy for stage IV NSCLC. RESULTS: In a risk-mitigation pandemic scenario, efforts should be made not to compromise the prognosis of lung cancer patients by departing from guideline-recommended radiotherapy practice. In that same scenario, postponement or interruption of radiotherapy treatment of COVID-19 positive patients is generally recommended to avoid exposure of cancer patients and staff to an increased risk of COVID-19 infection. In a severe pandemic scenario characterized by reduced resources, if patients must be triaged, important factors for triage include potential for cure, relative benefit of radiation, life expectancy, and performance status. Case-specific consensus recommendations regarding multimodality treatment strategies and fractionation of radiotherapy are provided. CONCLUSION: This joint ESTRO-ASTRO practice recommendation established pragmatic and balanced consensus recommendations in common clinical scenarios of radiotherapy for lung cancer in order to address the challenges of the COVID-19 pandemic.

Prioritization of Proton Patients in the COVID-19 Pandemic: Recommendations from The New York Proton Center.

It has been well documented from the early days of the 2019 novel coronavirus (COVID-19) pandemic that patients with a diagnosis of cancer are not only at higher risks of contracting a COVID-19 infection but also at higher risks of suffering severe, and possibly fatal, outcomes from the infection. Given that the United States has the greatest number of positive coronavirus cases, it is likely that many, if not all, radiation oncology clinics will be faced with the challenge of safely balancing a patient's risk of contracting COVID-19, while under active radiation treatment, against their risk of cancer progression if treatment is delayed. To address this challenge, the New York Proton Center established an internal algorithm that considers treatment-related, tumor-related, and patient-related characteristics. Despite having suffered staff shortages due to illness, this algorithm has allowed the center to maintain patient treatment volumes while keeping the rate of COVID-19 infection low.

Need for Caution in the Diagnosis of Radiation Pneumonitis During the COVID-19 Pandemic.

PURPOSE: Patients with cancer are at high risk for mortality from coronavirus disease 2019 (COVID-19). Radiation pneumonitis (RP) is a common toxicity of thoracic radiation therapy with clinical and imaging features that overlap with those of COVID-19; however, RP is treated with high-dose corticosteroids, which may exacerbate COVID-19-associated lung injury. We reviewed patients who presented with symptoms of RP during the intensification of a regional COVID-19 epidemic to report on their clinical course and COVID-19 testing results. METHODS AND MATERIALS: The clinical course and chest computed tomography (CT) imaging findings of consecutive patients who presented with symptoms of RP in March 2020 were reviewed. The first regional COVID-19 case was diagnosed on March 1, 2020. All patients underwent COVID-19 qualitative RNA testing. RESULTS: Four patients with clinical suspicion for RP were assessed. Three out of 4 patients tested positive for COVID-19. All patients presented with symptoms of cough and dyspnea. Two patients had a fever, of whom only 1 tested positive for COVID-19. Two patients started on an empirical high-dose corticosteroid taper for presumed RP, but both had clinical deterioration and ultimately tested positive for COVID-19 and required hospitalization. Chest CT findings in patients suspected of RP but ultimately diagnosed with COVID-19 showed ground-glass opacities mostly pronounced outside the radiation field. CONCLUSIONS: As this pandemic continues, patients with symptoms of RP require diagnostic attention. We recommend that patients suspected of RP be tested for COVID-19 before starting empirical corticosteroids and for careful attention to be paid to chest CT imaging to prevent potential exacerbation of COVID-19 in these high-risk patients.

Thoracic Radiation Therapy During Coronavirus Disease 2019: Provisional Guidelines from a Comprehensive Cancer Center within a Pandemic Epicenter.

Coronavirus disease 2019 is an unprecedented pandemic with significant and evolving impact on the practice of radiation oncology. Radiation oncology departments must anticipate and account for coronavirus disease 2019 exposure risk for both patients and staff. The potential for severe radiation therapy resource constraints, particularly due to staff illness, must also be considered. Here we present provisional guidelines for thoracic radiation therapy adopted at our facility, a high-volume cancer center located in a United States pandemic epicenter. Generally, these guidelines reflect the principle that where evidence-supported hypofractionated schedules with comparable efficacy and toxicity exist, the shortest such schedules should be employed. In addition, we discuss potential adaptations in the prioritization and timing of radiation therapy for thoracic malignancies under these circumstances.

Quantifying the Impact of COVID-19 on Cancer Patients: A Technical Report of Patient Experience During the COVID-19 Pandemic at a High-volume Radiation Oncology Proton Center in New York City.

The COVID-19 pandemic has rapidly spread across the world and now affects more people within the United States than any other country. New York City has emerged as the epicenter of the outbreak in the United States. Both locally and across the country, there is great concern in our ability to deliver appropriate medical care during this time. Radiation therapy is another essential clinical service that cannot afford to suffer prolonged delays without compromising patient outcomes. Early action and guidance are therefore critical to minimize transmission events and ensure safe and timely delivery of radiation therapy. The New York Proton Center (NYPC) is a high-volume free-standing multi-institutional proton center located in Manhattan. The purpose of this report is to describe the institutional patient experience and quantify the impact of treatment delays and interruptions over the first month of the COVID-19 outbreak. We also quantify the incidence of COVID-19 positive patients on census and provide guidance on proactive institutional policies to mitigate patient risk.